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A Histomorphometric Analysis Following Sinus Augmentation Using Two Different Bone Graft Materials.

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ClinicalTrials.gov Identifier: NCT03059914
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jaime Lozada, Loma Linda University

Brief Summary:
The purpose of this investigator-initiated study is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using two different bone graft materials. A total of twenty, sinus augmentation via a lateral approach will be performed for subjects requiring sinus augmentation for implant placement and randomly divided into 2 groups. These subjects will receive one of two different bone graft materials: 1) Anorganic bovine bone matrix- InterOss (Group A), 2) Anorganic bovine bone matrix- Bio-oss (Group B). At the time of implant placement (eight months after the sinus augmentation procedure), two bone biopsies will be collected from augmented site for the histomorphometric analysis. The percentage of vital bone will be measured and analyzed statistically, also the following will be measured: percentage of non-vital bone, percentage of non-bone material (xenograft), and the percentage of connective tissue.

Condition or disease Intervention/treatment Phase
Missing Teeth Device: InterOss Device: Bio-oss Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Histomorphometric Analysis of New Bone Formation Following Sinus Augmentation Using Two Different Bone Graft Materials. A Pilot Study in Humans.
Actual Study Start Date : August 10, 2017
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arm Intervention/treatment
Experimental: InterOss
Maxillary sinus augmentation using ABBM Inteross ( Xenograft)
Device: InterOss
Anorganic bovine bone mineral - Xenograft

Active Comparator: Bio-oss
Maxillary sinus augmentation using ABBM Bio-oss ( Xenograft)
Device: Bio-oss
Anorganic bovine bone mineral ( Xenograft)




Primary Outcome Measures :
  1. Percentage of new vital bone [ Time Frame: 8 months ]
    Vital bone as seen in histology



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 103 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Over 18 years old who are able to read and sign an informed consent form.
  2. Patient who has good oral hygiene (Full-mouth plaque score <25%).
  3. Subject would be available for study monitoring and follow-up visits.
  4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation for implant placement. The patients may be partially or completely edentulous.
  5. Patient is a candidate for delayed implant placement approximately 8 months following sinus grafting

Exclusion Criteria:

  1. Alcohol, drug dependency.
  2. Signs or symptoms of chronic maxillary sinus disease.
  3. Current smoker.
  4. History of head and neck radiation treatment.
  5. Poor health, conditions like uncontrolled diabetes, uncontrolled hypertension or other uncontrolled systemic disease.
  6. Physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.
  7. Also, subjects who are nursing or pregnant will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059914


Locations
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United States, California
Loma Linda University school of dentistry
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Loma Linda University
Investigators
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Principal Investigator: Jaime Lozada Loma Linda University

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Responsible Party: Jaime Lozada, Professor Program Director Implant Dentistry, Loma Linda University
ClinicalTrials.gov Identifier: NCT03059914     History of Changes
Other Study ID Numbers: 5170069
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Tooth Loss
Anodontia
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Tooth Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities